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Quality Assurance
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Diener Precision Pumps is certified to medical standard ISO 9001:2000 / ISO 13485:2003. In addition, we have clean-room according to ISO Class 7.
Production quality starts with the individual parts. We customize our own tooling and write our own CNC software to ensure consistency and repeatability of all parts. Statistical measurement controls are implemented at the machine, assuring that each part conforms to tolerance.
All assembly, manufacturing, inspection, and risk management procedures are 100% documented and updated daily. Products are 100% wet-tested prior to dispatch and the performance and lot controls can be traced by product serial number. We design/build our own automated test rigs and measurement jigs: all are optimized to reduce test time and production costs. |
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Certification
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ISO 9001:2000
ISO 13485:2003
DPP Embrach, CH |
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ISO 9001:2000
ISO 13485:2003
DPP Lodi, USA |
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